Medical device related pressure ulcers in Jordan: Prevalence study among critically ill patients

Abstract Background Medical device‐related pressure ulcers are increasingly common in critical care units. These ulcers can be complicated due to the necessity of the device for diagnosis or treatment. Purpose To determine the prevalence of and risk for medical device‐related pressure ulcers in critical care units in Jordan in addition to identifying the preventive measures for those ulcers as well as identifying the most frequently used medical devices that cause ulcers and to assess the relationships between prevention measures and developing ulcers. Methods A cross‐sectional survey was used to assess ulcers among 318 patients who were elder than 18 years old. Data collection was based on an outline published by the European Pressure Ulcer Advisory Panel, Braden Scale, and an author‐developed specific checklist. Results The prevalence rate of medical device‐related pressure ulcers was 38.1%. Most affected sites were sacrum and heel, and most affected were those with old age, being admitted to public hospitals, and with a prolonged hospital stay. About half of the patients (46.3%) had severe risk. Only 17% of the patients who were at risk got adequate preventive measures. Face masks, endotracheal tubes, pulse oximetry probes, and intravenous catheters were associated with almost half of the ulcers. Conclusion Medical device‐related pressure ulcers are threats to patient safety and quality of nursing care in hospitals, which require determining appropriate preventive measures. Key messages: Medical device‐related pressure ulcers are common among patients in critical care units, which raise the need to evaluate the prevalence of such type of ulcers in those patients. Three hundred and eighteen patients were investigated for the prevalence of medical device‐related pressure ulcers through a cross‐sectional survey. Patients in critical care units in Jordan had a high prevalence rate for medical device‐related pressure ulcers, which require the need to apply appropriate preventive measures.


| INTRODUCTION
The employment of advanced technology is essential to provide care for hospitalized patients, especially in critical care units (CCUs). Using medical devices (MDs) in physically compromised critically ill adults, children and trauma/orthopedic patients are pervasive in sustaining life and promoting healing during patients' hospital stay. 1,2 With the MDs used, however, the risk of an MDs-related pressure ulcer (MDRPrUs) or "pressure injury" is inevitable. 3 For instance, critically ill patients who are on a sustained life support system are 2.4 times more probable to acquire hospital-acquired pressure ulcers (HAPUs) when being compared to patients without a device during their hospital stay. 1,4,5 The MDRPrUs were defined as "the injury that results from any MD used for diagnosis or treatment and this injury could be fit in the shape of the MD". 6 Pressure ulcers (PrUs) are the main health alteration, which results in decreased value of life and increased demands on healthcare systems globally. However, PrUs are largely preventable when available clinical guidelines available are applied by clinicians. 7 While the prevalence and prevention of common types of PrUs in adult patients have been extensively explored. 8 The correlation of MDs with acquiring PrUs in hospitalized patients is not well defined. 9 The National Pressure Ulcer Advisory Panel (NPUAP), however, has set studying MDRPrUs as a priority. 10 Few studies have captured information on MDRPrUs among critically ill patients. Coyer et al. 11 conducted a prospective study and assessed the prevalence, severity, sites, etiology, treatment, and healing of MDRPrUs in critical care patients in Australia and the USA.
Coyer et al. 11 reported that 3.1% had MDRPrUs with an average age of 60.5 years, and most of them were men and overweight.
Endotracheal tubes (ET) and nasogastric tubes (NGT) were the reason for most MDRPrUs, and repositioning (changing MD position to relieve pressure on the ulcer) was the most common treatment for MDRPrUs (not changing MD position can exacerbate MDRPrUs).
Similar to our study's methods and population, a recent point prevalence cross-sectional study found that the prevalence of MDRPrUs was 19.2% in 146 critically ill adult patients from India. 12 The MDRPrUs were mostly caused by noninvasive ventilation masks (NIV) and NGT and were associated with a longer stay in intensive care units (ICU). In a closer figure to the Jordanian population, Amirah et al. 13  Other researchers reported that the percentage of PUs could reach up to 49% of the ICU patients 14 and the majority (68%) occurring in intensive care. 15 Hence, under-reporting of MDRPrUs is evident because nearly 74% of them are not clinically recognized till they are unstageable, stage III, or stage IV, and there has been poor documentation of device removal, and pressure relief, and/or skin inspections. Most of the studies revealed that stage II is considered the most common MDRPrUs. 1,16 PrUs are categorized based on NPUAP and the European Pressure Ulcer Advisory Panel (EPUAP) Classification System into six stages: unstageable, suspected deep tissue injury, stages I-IV. 6 It is challenging to compare the prevalence and incidence of MDRPrUs due to variations in the population under investigation, the location, and stage of ulcers, and the MDs used. For instance, 35% of MDRPrUs developed on the ears 1 in an adult population, and nearly 50% were developed on the nose and the feet of neonates and children. The overall prevalence of MDRPrUs has been reported globally with variable values; for example, Amirah et al. 13 found that the prevalence of MDRPrUs in Saudi Arabia was 29.7%. However, Coyer et al. 11 reported in their study in the USA and Australia that the prevalence rate of MDRPrUs was 4.1%. On the contrary, Kayser et al. 17 found in their study in the USA and Canada that the prevalence rate of MDRPrUs was 0.6%.
Regarding the devices that cause the MDRPrUs, ET tube and Foley's catheters, 13 cervical collar or braces, 2 oxygen therapy tubes and masks, 12 and feeding tubes such as nasogastric and jejunal tubes were reported as the most common devices that cause MDRPrUs. 12 The following factors can increase the possibility and risk of developing MDRPrUs: hard device material, improper choice of MD, attaching MD on an area with little fat tissue, moisture condition of the skin where the device is attached, improper fixation method, improper use of adhesive tape, using many types of MDs, and using MD on the same area for a long period. 18 In general, old age and male gender, prolonged hospital stay, and having PrUs in the body are major risk factors that increase the possibility of developing MDRPrUs. 19 In the Middle East, evidence has revealed that common types of PrUs lack adequate documentation, risk assessment, training, prevention, and treatment guidelines for nurses. 20 Only one published work on the prevalence of MDRPrUs among critically ill patients has been found in the Arab world, providing prevalence numbers from the Kingdom of Saudi Arabia. 13 The purpose of this study is to describe the prevalence of and the most communal MDs

| Ethical considerations
Ethical authorization was obtained from the institutional review board committee in the university where the principal researcher works; additional approvals were obtained from ethical research committees in the participating hospitals. Each patient or his first-degree relative (if the patient's level of consciousness was 8 or less according to the Glasgow coma scale assessment by the caring team) was asked to sign a consent form for participation in the survey. The patient's right to withdraw from the research study at any stage was guaranteed.

| Data collection
A list of patients was obtained from the Directors of Nursing of each targeted hospital on the assigned day for data collection. A critically ill patient is defined as a patient with severe respiratory, cardiovascular, or neurological alterations, often in combination, and are reflected in abnormal physiological observations. 21 All patients at selected CCUs were assessed for eligibility criteria and those patients who conformed to the following were included in the study; aged 18 years and above, admitted before midnight on the predefined day of data collection, using MD at the time of the study, having pressure ulcer (PU) stages I-IV according to the NPUAP, EPUAP classification system 6 as assessed by the nursing staff caring for them and the researcher, and patients with a Braden score of ≤18.
Each patient was assessed by a wound care nurse assigned in each hospital selected, so 10 nurses assisted in the data collection procedure. Those nurses were trained about how to use the data collection measures in assessing the target patients (i.e.: how to calculate prevalence, risk assessment, how to use the Braden scale, in addition to orientation about MDs that could cause PrUs). The training program lasted for 2 days, then each nurse was asked to use the data collection measures clinically on two patients (not from the original sample) therefore the pilot study sample was 20 patients.
These nurses displayed almost 0.90 interclass correlation coefficient in grading results of risk assessment and Braden scale and were consistent with the assessment done by one of this study's investigators who is a tissue viability nurse specialist.
Observations for patients selected for the study by the assigned nurses to collect data were managed in unscheduled visits through the day and night shifts. Assessment of patient skin was carefully performed and each patient was assessed for PrUs on daily basis during the data collection period identified below. PrUs from stage I (nonblanchable erythema) to stage IV (widespread destruction of the skin and underlying tissue), deep-tissue injury, and unstageable ulcers were identified according to the NPUAP, EPUAP classification system. 6 Risk assessment and the use of preventive measures were documented. After completing data collection, data sheets were checked and any absent data were added. The data were collected between August and November 2019.

| Measures
Data were collected using a modified form based on the EPUAP pressure ulcer prevalence survey form, which has been validated and showed high interrater reliability. 22 The initial form of the survey was subjected to a validation process and pilot testing by the researchers and a group of expert wound care nurses (n = 10) from a university teaching hospital.
This improved the content validity of the form, the level of comprehensiveness, clarity, and reduced ambiguity. The modified survey form included data across five categories: general patient data, risk assessment   26 and wheelchairs. 33 The fourth category includes clinical assessment of the patient's skin. All patients at risk for PU (Braden score ≤ 18) were examined for the presence of PU, PU stages, and PU location using the NPUAP, EPUAP classification system. 34 The last category of the survey is the prevention measures used as recorded by the caring team. Prevention included skin inspection, handling of the patient's body, supporting MD (defined as padded skin before device application and/or no support used), use of PU prevention guidelines, using skin barrier creams, nutritional screening, and nutritional supplements, MD repositioning as well as patient repositioning which are documented as planned frequently, or not planned/irregular.

| Data analysis
Descriptive analysis of data was accomplished using IBM SPSS 24.0. 35 Preliminary data screening was conducted to identify any missing data. Descriptive statistics including frequencies were used to describe study variables. All percentages were rounded to the nearest digit. The prevalence of MDRPrUs was calculated based on the number of patients who developed MDRPrUs and the total number of patients included in the sample.

| RESULTS
The number of patients congruent with the inclusion criteria in the selected hospitals was 348 critically ill patients, 13 patients dropped and 17 patients were not obtainable at the time of screening to give a final sample of 318 patients. The demographic characteristics are shown in Table 1. Only hospital sector, age, and length of patient stay in hospital were significantly correlated with the occurrence of MDRPrUs, that is increasing age and prolonged length of stay in hospital as well as being admitted to public hospitals increased the risk for MDRPrUs.  Table 3). Our study results showed a statistically significant (p < 0.001) relationship between the Braden scores and the MDRPU development.  Table 4 demonstrated that none of the correlations were statistically significant at α = 0.05 using the chi-squared test. As all prevention and treatment variables were not significant, performing regression analysis to elucidate a prediction model among those who developed

| PrUs prevention in patients who had MDRPrUs
MDRPUs was useless and therefore the study results were dependent mainly on correlations.

| Medical device-related pressure ulcers (MDRPrUs)
Our study indicated the use of 26 MDs in CCUs in Jordan. The frequently used MDs are shown in Table 5 We aim to standardize these protocols to provide the best care across the country. As MDRPrUs are a growing problem, we advise further research in the hope of reaching a consensus on prevention strategies, detection, and treatment of this disease. Although we excluded patients who were younger than the age of 18 years, we cannot deny the high prevalence of MDRPrUs in the younger age group, which was found to be 10% for children. 38 This encourages us to investigate MDRPrUs in different age groups in the future.

| Strengths
The participants in the current study included patients from different centers across Jordan, which adds strength to this study. In addition, the use of the EPUAP grading system facilitated homogenizing the results throughout the study population.

| Limitations
The exclusion of certain patients, such as those younger than 18  Writing-reviewing and editing: Yahya W. Najjar.

ACKNOWLEDGMENTS
This study was funded by the University of Jordan (approval Number: 161/2016-2017). The role of funding source was in data collection.

CONFLICTS OF INTEREST
The authors declare no conflicts of interest.

DATA AVAILABILITY STATEMENT
The authors confirm that the data supporting the findings of this study are available within the article. All authors have read and approved the final version of the manuscript and had full access to all of the data in this study and takes complete responsibility for the integrity of the data and the accuracy of the data analysis.

ETHICS STATEMENT
Ethical approval to conduct the study was obtained from the university in which primary investigators works and from the hospitals selected as settings for the study.

CLINICAL IMPLICATIONS
Medical device-related pressure ulcers are a crucial marker of patient safety and nursing quality in providing care to patients. Hence, crucial preventive measures for MDRPrUs are needed in Jordanian hospitals, and a scientific approach to MDRPrUs before and when occurred is nonetheless to be devised in Jordanian hospitals. We encourage further research in this field to raise awareness of this problem among the healthcare team.

TRANSPARENCY STATEMENT
The lead author affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.